NCT01049737

Brief Summary

The purpose of this study is to prospectively explore the impact from the different cardiovascular risk factors on early cardiovascular organ damage in 761 middle aged patients with type 2 diabetes.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
761

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2005

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2005

Completed
4.7 years until next milestone

First Submitted

Initial submission to the registry

January 13, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 14, 2010

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2012

Completed
Last Updated

March 8, 2018

Status Verified

March 1, 2018

Enrollment Period

7.6 years

First QC Date

January 13, 2010

Last Update Submit

March 7, 2018

Conditions

Diabetes Mellitus Type 2Cardiovascular Diseases

Outcome Measures

Primary Outcomes (1)

  • Left ventricular mass index by cardiac ultrasonography, Intima media thickness by carotid ultrasonographic investigation and tonometry for measurements of the carotid, femoral and radial pulse pressure wave form and pulse wave velocity

    4 years after baseline investigation

Secondary Outcomes (1)

  • Cardiovascular morbidity and mortality

    8-12 years after baseline investigation

Eligibility Criteria

Age55 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The patients in CARDIPP were consecutively recruited from primary health care centres in the counties of Östergötland and Jönköping, Sweden from November 2005 through December 2008. The study enrolled 761 patients with type 2 diabetes, aged 55-65 years and the participation in the study was performed as an extended annual follow up.

You may qualify if:

  • Clinical diagnosis of type 2 diabetes

You may not qualify if:

  • Not able to understand Swedish

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Medical and Health Sciences, Linköping University

Linköping, SE-581 83, Sweden

Location

Related Publications (17)

  • Dahlen EM, Lanne T, Engvall J, Lindstrom T, Grodzinsky E, Nystrom FH, Ostgren CJ. Carotid intima-media thickness and apolipoprotein B/apolipoprotein A-I ratio in middle-aged patients with Type 2 diabetes. Diabet Med. 2009 Apr;26(4):384-90. doi: 10.1111/j.1464-5491.2009.02693.x.

    PMID: 19388968RESULT

  • Wijkman M, Lanne T, Engvall J, Lindstrom T, Ostgren CJ, Nystrom FH. Masked nocturnal hypertension--a novel marker of risk in type 2 diabetes. Diabetologia. 2009 Jul;52(7):1258-64. doi: 10.1007/s00125-009-1369-9. Epub 2009 Apr 25.

    PMID: 19396423RESULT

  • Davidson LT, Chisalita SI, Gauffin E, Engvall J, Ostgren CJ, Nystrom FH. Plasma copeptin independently predicts cardiovascular events but not all-cause mortality in patients with type 2 diabetes: a prospective observational study. Nutr Metab Cardiovasc Dis. 2025 Nov;35(11):104158. doi: 10.1016/j.numecd.2025.104158. Epub 2025 May 19.

    PMID: 40617713DERIVED

  • Vergara M, Ostgren CJ, Nystrom FH, Israelsson H. Sense of vitality is associated with cardiovascular events in type 2 diabetes independently of traditional risk factors and arterial stiffness. Diabet Med. 2023 Feb;40(2):e14938. doi: 10.1111/dme.14938. Epub 2022 Aug 30.

    PMID: 36039920DERIVED

  • Johansson MA, Vavruch C, Ostgren CJ, Nystrom FH. Circulating TNFrII levels predict incidence of ischemic heart disease and total mortality, independently of intima media thickness and pulse wave velocity in male with type 2 diabetes. Heart Vessels. 2021 Oct;36(10):1591-1596. doi: 10.1007/s00380-021-01857-4. Epub 2021 Apr 19.

    PMID: 33871700DERIVED

  • Vavruch C, Nowak C, Feldreich T, Ostgren CJ, Sundstrom J, Soderberg S, Lind L, Nystrom F, Arnlov J. Using proximity extension proteomics assay to discover novel biomarkers associated with circulating leptin levels in patients with type 2 diabetes. Sci Rep. 2020 Aug 4;10(1):13097. doi: 10.1038/s41598-020-69473-2.

    PMID: 32753620DERIVED

  • Chisalita SI, Wijkman M, Davidson LT, Spangeus A, Nystrom F, Ostgren CJ. Toe brachial index predicts major acute cardiovascular events in patients with type 2 diabetes independently of arterial stiffness. Diabetes Res Clin Pract. 2020 Mar;161:108040. doi: 10.1016/j.diabres.2020.108040. Epub 2020 Jan 29.

    PMID: 32006647DERIVED

  • Blomstrand P, Sjoblom P, Nilsson M, Wijkman M, Engvall M, Lanne T, Nystrom FH, Ostgren CJ, Engvall J. Overweight and obesity impair left ventricular systolic function as measured by left ventricular ejection fraction and global longitudinal strain. Cardiovasc Diabetol. 2018 Aug 14;17(1):113. doi: 10.1186/s12933-018-0756-2.

    PMID: 30107798DERIVED

  • Radholm K, Tengblad A, Dahlen E, Lanne T, Engvall J, Nystrom FH, Ostgren CJ. The impact of using sagittal abdominal diameter to predict major cardiovascular events in European patients with type 2 diabetes. Nutr Metab Cardiovasc Dis. 2017 May;27(5):418-422. doi: 10.1016/j.numecd.2017.02.001. Epub 2017 Feb 16.

    PMID: 28390663DERIVED

  • Wijkman M, Lanne T, Ostgren CJ, Nystrom FH. Aortic pulse wave velocity predicts incident cardiovascular events in patients with type 2 diabetes treated in primary care. J Diabetes Complications. 2016 Sep-Oct;30(7):1223-8. doi: 10.1016/j.jdiacomp.2016.06.008. Epub 2016 Jun 19.

    PMID: 27400814DERIVED

  • Jennersjo P, Guldbrand H, Bjorne S, Lanne T, Fredrikson M, Lindstrom T, Wijkman M, Ostgren CJ, Nystrom FH. A prospective observational study of all-cause mortality in relation to serum 25-OH vitamin D3 and parathyroid hormone levels in patients with type 2 diabetes. Diabetol Metab Syndr. 2015 Jun 12;7:53. doi: 10.1186/s13098-015-0049-9. eCollection 2015.

    PMID: 26078787DERIVED

  • Vavruch C, Lanne T, Fredrikson M, Lindstrom T, Ostgren CJ, Nystrom FH. Serum leptin levels are independently related to the incidence of ischemic heart disease in a prospective study of patients with type 2 diabetes. Cardiovasc Diabetol. 2015 May 22;14:62. doi: 10.1186/s12933-015-0208-1.

    PMID: 25994184DERIVED

  • Dahlen EM, Tengblad A, Lanne T, Clinchy B, Ernerudh J, Nystrom FH, Ostgren CJ. Abdominal obesity and low-grade systemic inflammation as markers of subclinical organ damage in type 2 diabetes. Diabetes Metab. 2014 Feb;40(1):76-81. doi: 10.1016/j.diabet.2013.10.006. Epub 2013 Nov 26.

    PMID: 24290615DERIVED

  • Dahlen EM, Bjarnegard N, Lanne T, Nystrom FH, Ostgren CJ. Sagittal abdominal diameter is a more independent measure compared with waist circumference to predict arterial stiffness in subjects with type 2 diabetes--a prospective observational cohort study. Cardiovasc Diabetol. 2013 Mar 28;12:55. doi: 10.1186/1475-2840-12-55.

    PMID: 23536999DERIVED

  • Wijkman M, Lanne T, Grodzinsky E, Ostgren CJ, Engvall J, Nystrom FH. Ambulatory systolic blood pressure predicts left ventricular mass in type 2 diabetes, independent of central systolic blood pressure. Blood Press Monit. 2012 Aug;17(4):139-44. doi: 10.1097/MBP.0b013e328355fdfb.

    PMID: 22735793DERIVED

  • Jennersjo P, Ludvigsson J, Lanne T, Nystrom FH, Ernerudh J, Ostgren CJ. Pedometer-determined physical activity is linked to low systemic inflammation and low arterial stiffness in Type 2 diabetes. Diabet Med. 2012 Sep;29(9):1119-25. doi: 10.1111/j.1464-5491.2012.03621.x.

    PMID: 22364114DERIVED

  • Jennersjo PE, Wijkman M, Wirehn AB, Lanne T, Engvall J, Nystrom FH, Ostgren CJ. Circadian blood pressure variation in patients with type 2 diabetes--relationship to macro- and microvascular subclinical organ damage. Prim Care Diabetes. 2011 Oct;5(3):167-73. doi: 10.1016/j.pcd.2011.04.001. Epub 2011 May 5.

    PMID: 21546328DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Blood samples were drawn in the fasting state and analysed for levels of HbA1c, hs-CRP, cytokines, lipid and lipoprotein status etc. RNA is extracted from whole blood and the PPAR-gamma isoform was determined after RT-PCR and analysis of DNA sequence. Several small vials of plasma and serum are stored for later analysis of different hormones, cytokines and antibodies (when the economy of the project allows this, high priority is antibodies against GAD and islet beta-cells and levels of hormones such as resistin, adiponectin, leptin and markers of inflammation in terms of cytokines as IL-1, IL-6, IL-10). Other genetic polymorphisms of importance for risk assessment will also be analysed when the economy allows this.

MeSH Terms

Conditions

Diabetes Mellitus, Type 2Cardiovascular Diseases

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Carl J Östgren, PhD

    Linkoeping University

    STUDY DIRECTOR

  • Fredrik H Nyström, Professor

    Linkoeping University

    PRINCIPAL INVESTIGATOR

  • Toste Länne, Professor

    Linkoeping University

    PRINCIPAL INVESTIGATOR

  • Jan Engvall, PhD

    Linkoeping University

    PRINCIPAL INVESTIGATOR

  • Torbjörn Lindström, PhD

    Linkoeping University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor, MD PhD

Study Record Dates

First Submitted

January 13, 2010

First Posted

January 14, 2010

Study Start

May 1, 2005

Primary Completion

December 1, 2012

Study Completion

December 1, 2012

Last Updated

March 8, 2018

Record last verified: 2018-03

Locations

SE(1)